Events

Rappel de Organogenesis Apligraf

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Organogenesis, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56543
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2589-2010
  • Date de mise en oeuvre de l'événement
    2010-08-02
  • Date de publication de l'événement
    2010-09-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93893
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Wound and Burn Interactive Dressing - Product Code MGR
  • Cause
    Product is contaminated with a yeast identified as pseudozyma antarctica.
  • Action
    Organogenesis notified accounts by telephone, e-mail or fax on 8/2/010 to remove from use and return recalled units. If unit was applied to patient then monitor for adverse events. The Notification Letter dated August 6, 2010, described the issue and provided instructions for customers. Customers are to place the affected unit on hold for its return to the firm. The firm will contact customers to make arrangements for its return. Replacements have already been sent. If the affected unit has already been applied, the patients should be monitored closely for any potential adverse events. An Organogenesis Medical Affairs rep will be in contact regarding patient follow up. Customers are to complete the attached form and fax it back to the number provided. Questions should be directed to the Medical Information Center at 1-888-432-5232.

Device

Organogenesis Apligraf
  • Modèle / numéro de série
    Lot # GS1007.06.03.1A Unit numbers: 146-, 148, 149, 150, 151, 152, 154, 155, 157, 158, 159, 160, 162, 163, 172, 173, 174, 175, 176, 177, 178, 180, 181, 182, 184, 185, 186, 187, 188, 189, and 190.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- AL, AZ, CA, CO, IL NC, PA, TN, and VA.
  • Description du dispositif
    Apligraf is supplied as a living, bi-layered skin substitute. || Article Number: GS100 || Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
  • Manufacturer
    Organogenesis, Inc.

Manufacturer

Organogenesis, Inc.
  • Adresse du fabricant
    Organogenesis, Inc., 150 Dan Road, Canton MA 02021-2820
  • Source
    USFDA